18 months follow-up of deep molecular response 4.5 (MR4.5) with nilotinib in patients with newly diagnosed chronic-phase chronic myeloid leukemia: a prospective, multi-center study in China

Bingbing Wen; Yuming Zhang; Haiqing Lin; Jin Lou; Chuangqing Tu; Yirong Jiang; Xiaolian Liu; Yan Chen; Huiqing He; Zelin Liu; Xiaoling Xie; Wangxiang Huang; Liping Pang; Xin Du

doi:10.3389/fmed.2023.1267512

18 months follow-up of deep molecular response 4.5 (MR^4.5) with nilotinib in patients with newly diagnosed chronic-phase chronic myeloid leukemia: a prospective, multi-center study in China

Front Med (Lausanne). 2023 Nov 16:10:1267512. doi: 10.3389/fmed.2023.1267512. eCollection 2023.

Authors

Bingbing Wen^#¹, Yuming Zhang^#², Haiqing Lin^#³, Jin Lou¹, Chuangqing Tu⁴, Yirong Jiang⁵, Xiaolian Liu⁶, Yan Chen⁷, Huiqing He⁸, Zelin Liu⁹, Xiaoling Xie¹⁰, Wangxiang Huang¹¹, Liping Pang¹², Xin Du¹

Affiliations

¹ Department of Hematology, The Second People's Hospital of Shenzhen, The First Affiliated Hospital of Shenzhen University, Shenzhen, China.
² Department of Hematology, Affiliated General Hospital of Guangdong Medical University, Zhanjiang, China.
³ Department of Hematology, Shenzhen People's Hospital, Shenzhen, China.
⁴ Department of Hematology, Shenzhen Baoan People's Hospital, Shenzhen, China.
⁵ Department of Hematology, Dongguan People's Hospital, Dongguan, China.
⁶ Department of Hematology, Gaozhou People Hospital, Gaozhou, China.
⁷ Department of Hematology, The Eighth Affiliated Hospital, Sun Yat-sen University, Shenzhen, China.
⁸ Department of Hematology, Zhongshan City People's Hospital, Zhongshan, China.
⁹ Department of Hematology, Huazhong University of Science and Technology Union Shenzhen Hospital (Nanshan Hospital), Shenzhen, China.
¹⁰ Department of Hematology, Huizhou Municipal Central Hospital, Huizhou, China.
¹¹ Department of Hematology, Shenzhen Longgang Central Hospital, Shenzhen, China.
¹² Department of Hematology, Peking University Shenzhen Hospital, Shenzhen, China.

^# Contributed equally.

Abstract

Introduction: Early stable deep molecular response (DMR) to nilotinib is associated with goal of treatment-free remission (TFR) in patients with chronic-phase chronic myeloid leukemia (CML-CP). It is important to early distinguish between patients who can achieve a DMR and those who are fit for TFR.

Methods: We performed a multicenter study to explore the early cumulative MR^4.5 rate at 18 months with nilotinib in patients with newly diagnosed CML-CP (ND-CML-CP) in China. Of the 29 institutes, 106 patients with ND-CML-CP received nilotinib (300 mg BID).

Results and discussion: The cumulative MR^4.5 rate of nilotinib treatment at 18 months was 69.8% (74/106). The cumulative MMR and MR^4.0 rates for nilotinib at 18 months were 94.3% (100/106) and 84.9% (90/106), respectively. Patients with an ultra-early molecular response (u-EMR) at 6 weeks were not significantly different in obtaining DMR or MMR by 24 months compared with those without u-EMR (p = 0.7584 and p = 0.9543, respectively). Our study demonstrated that nilotinib treatment in patients with ND-CML-CP contributed to obtain high early MR^4.5.

Keywords: 18 months; chronic-phase chronic myeloid leukemia; deep molecular response; newly diagnosed; nilotinib.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was supported by Shenzhen Key Medical Discipline (No. SZXK008).